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510(k) Data Aggregation

    K Number
    K973108
    Device Name
    TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-03-02

    (195 days)

    Product Code
    CEK
    Regulation Number
    862.1635
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). For IN VITRO diagnostic use.

    Device Description

    Total Protein (Micro) Assay

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "Total Protein (Micro) Assay" device. It does not contain information about acceptance criteria, device performance, specific study details, or ground truth establishment.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF) for in vitro diagnostic use. It outlines the regulatory classification, general controls, and other regulatory information but does not include the type of detailed study information requested.

    Therefore, I cannot provide the requested table and study details based on the input text.

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